BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT

    MDR report key: 7335869 · Received March 13, 2018

    Report

    Report Number
    1017768-2018-00025
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    February 12, 2018
    Report Date
    August 17, 2018
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    SUBMISSION DATE: 08/17/2018. AN INVESTIGATION WAS PERFORMED FOR THE REPORTED CUSTOMER COMPLAINT: ¿THE CUSTOMER STATES WHILE DRAWING UP MEDICATION IN THE IV ROOM, A CRACK WAS IDENTIFIED IN A COVIDIEN MONOJECT 3 ML SYRINGE WITH AN 18G COVIDIEN MONOJECT STANDARD HYPODERMIC NEEDLE ATTACHED. MEDICATION LEAKED OUT OF SYRINGE CAUSING MEDICATION TO BE WASTED.¿ A REVIEW OF THE DEVICE HISTORY RECORD (DHR) OF THE REPORTED LOT NUMBER S14358 INDICATES THAT PRODUCT AND SPECIFICATION REQUIREMENTS WERE MET WITH NO NON-CONFORMING PRODUCT IDENTIFIED RELATING TO THIS CUSTOMER REPORT. DURING THE MANUFACTURING OF THE SYRINGE ASSEMBLIES, SYRINGES ARE VISUALLY INSPECTED AND PHYSICALLY TESTED. SAMPLES ARE ALSO INSPECTED FOR HUB LEAKAGE AND DAMAGE. THERE WERE NO (NON-CONFORMANCE RECORDS (NCRS) ISSUED TO THIS LOT OR THE PRINT BARRELS (ITEM NO. 3160705) UTILIZED IN THE PRODUCTION OF THIS LOT. A LOT CANNOT BE RELEASED UNLESS IT PASSES ALL QUALITY AND CONFORMANCE REQUIREMENTS. IN-PROCESS PROCEDURES ARE ALSO IN PLACE TO PREVENT NONCONFORMING PRODUCT IN THE MANUFACTURING PROCESS. THIS ENSURES COMPONENTS AND FINISHED PRODUCTS MEET ALL QUALITY INSPECTION STANDARDS. THESE CONTROLS INCLUDE, BUT ARE NOT LIMITED TO: MATERIAL VERIFICATION/CERTIFICATION PROCESSES, DIMENSIONAL SPECIFICATIONS, STATISTICAL SAMPLINGS, PERIODIC AUDITS, PROCESS INSPECTIONS, MACHINE MAINTENANCE/OPERATION AND PERSONNEL TRAINING AND CERTIFICATION. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. ONE (1) OPENED SAMPLE WAS PROVIDED FROM THE CUSTOMER. A VISUAL EXAMINATION OF THE SAMPLE NOTED A CRACK, APPROXIMATELY 1.5¿ IN LENGTH, RUNNING AXIALLY DOWN THE SIDE OF THE SYRINGE BARREL. A 6M ROOT CAUSE INVESTIGATION WAS CONDUCTED AND EVALUATED POTENTIAL CONTRIBUTING FACTORS. THE ANALYSIS DID NOT IDENTIFY ANY ISSUES WITH THE MANUFACTURING PROCESS. BASED ON THE AVAILABLE INFORMATION THERE¿S INSUFFICIENT EVIDENCE AVAILABLE TO DETERMINE A PROBABLE ROOT CAUSE FOR THIS INVESTIGATION. THE REPORTED CUSTOMER COMPLAINT IS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. NO CORRECTIVE OR PREVENTIVE ACTION IS PLANNED AT THIS TIME. THIS COMPLAINT WILL BE USED FOR TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES WHILE DRAWING UP MEDICATION IN THE IV ROOM, A CRACK WAS IDENTIFIED IN A COVIDIEN MONOJECT 3 ML SYRINGE WITH AN 18G COVIDIEN MONOJECT STANDARD HYPODERMIC NEEDLE ATTACHED. MEDICATION LEAKED OUT OF SYRINGE CAUSING MEDICATION TO BE WASTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178767 MONOJECT CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY FMF COVIDIEN 1180300777 S14358

    Patients

    Seq Age Sex Outcome Treatment
    1